US-based biopharmaceutical firm Novavax has started patient enrolment in a Phase II clinical trial of its respiratory syncytial virus (RSV) F-protein nanoparticle vaccine candidate (RSV F vaccine), in healthy elderly patients aged 60 and over.
The trial is designed to assess the incidence of all respiratory illnesses due to RSV, including medically-attended respiratory illnesses.
This includes hospitalisations for respiratory illness in community-living elderly adults who have been treated with a placebo.
Around 1,600 elderly patients at ten sites in the US will be enrolled in the randomised, observer-blinded, placebo-controlled trial, which will also evaluate the safety and immunogenicity of a 135ug dose of the RSV F vaccine compared with placebo.
Efficacy of the RSV F vaccine in reducing the incidence of respiratory illnesses due to RSV will be estimated in the trial.
Novavax CEO Stanley Erck said: "The initiation of this elderly clinical trial, shortly after the initiation of our Phase II maternal immunisation trial last month, demonstrates our commitment to the strategy of building an RSV franchise.
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"The goal of that strategy is to maximise the value of this product candidate for susceptible populations, the medical community, and our shareholders.
"Today there is a significant unmet medical need for an RSV vaccine for the approximately 57 million individuals over the age of 60 in the US. This suggests that the elderly market may be the largest value driver in our RSV franchise."
RSV is a major respiratory pathogen with a significant burden of disease in the very young and in the elderly population.
According to the company, the trial will evaluate RSV respiratory illness incidence rates in the elderly population in a prospective manner. Novavax will further develop its safety and immunogenicity database in older adults and offer an estimate of the RSV F vaccine’s efficacy.
Novavax SVP of research and development Greg Glenn said: "Answers to these questions will inform the design of our projected Phase III pivotal study.
"It is our goal to commence three RSV clinical trials in the fourth quarter, furthering the development of our RSV F vaccine in each of the three key target populations: young infants via maternal immunization, children beyond infancy, and the elderly.
"We look forward to initiation of our Phase 1 Pediatric RSV study later this quarter."
Image: Transmission electron micrograph of RSV. Photo: courtesy of CDC/ Dr Erskine Palmer.